Catheter Modification Device

By installing a flaring device at the entry port of the medical catheter, the problem of insufficient cross-sectional size of the catheter entry port is solved, and the smooth passage of the medical device and the good guidance of the catheter in the patient's vasculature is achieved.

CN114222602BActive Publication Date: 2025-02-25MEDTRONIC VASCULAR INC
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Patent Information

Application Number
CN202080056551.3
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Priority Date
2019-08-13
Filing Date
2020-08-10
Publication Date
2025-02-25
Estimated Expiration
2040-08-10

AI Technical Summary

Technical Problem

The inclusion of the inlet port of the existing medical catheter is insufficient, which causes the medical device to easily get stuck when interspersed in the catheter lumen, affecting the guiding nature of the catheter in the patient's vasculature.

Method used

By installing a flaring device at the inlet port of the conduit, the pin is pushed into the inlet port of the conduit using a combination of the housing and the pin, increasing the cross-sectional dimension of the inlet port, thereby forming a flaring.

Benefits of technology

The cross-sectional size of the catheter entry port is increased, reducing interception of medical devices at the entry port, and improving the catheter's guidance in the patient's vasculature and the efficiency of medical procedures.

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Abstract

The catheter flaring device (560) includes a housing and a pin (550). The housing includes an inner surface (564) defining a cavity (566), the cavity being configured to receive at least a portion of a catheter having an access port (508) and to engage an outer surface (503) of the catheter (502) proximal to the access port. The pin is configured to be advanced into the access port of the catheter to increase the cross-sectional size of the access port. During a medical procedure, flaring the access port can help reduce the possibility of a medical device getting stuck on the access port of the catheter.
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Description

Technical Field

[0001] The present disclosure relates to medical devices. Background Art

[0002] Medical catheters can be used in conjunction with various medical procedures. For example, in some cases, a medical catheter can be used to deliver a medical device and / or composition within a patient's vascular system. Summary of the invention

[0003] Exemplary devices described herein, systems and techniques can be used to increase the cross-sectional dimensions (e.g., diameter in the case of a circular cross section) of the access port that enters the catheter lumen. In some instances, the access port can be at the proximal end of a catheter, and in other instances, such as in the case of a guided extension catheter, the access port can be at the distal end of the proximal end of a catheter. Increase the outer cross-sectional dimensions of the access port, referred to herein as "flaring" of the access port, the access port can be widened without increasing the outer cross-sectional diameter of the other parts (e.g., distal portion) of the catheter, which can be convenient for introducing medical devices into the catheter lumen without adversely affecting the guiding of the vascular system of the catheter through the patient. In some instances, the flaring device has a pin, which is configured to be advanced into the access port of a catheter, to increase the cross-sectional dimensions of at least a portion of the access port. Enabling the access port to expand can reduce the interception of medical devices on the access port, which can be convenient for using the inner catheter that limits the outer diameter and the medical procedure of the outer catheter that limits the inner diameter greater than the inner catheter outer diameter.

[0004] In some examples, the present disclosure describes a device including a housing and a pin. The housing includes an inner surface defining a cavity configured to receive at least a portion of a catheter having an access port. The inner surface of the housing is configured to engage an outer surface of the catheter proximal to the access port. The pin is configured to be advanced into the access port of the catheter when at least a portion of the catheter is positioned in the cavity so as to increase the cross-sectional size of the access port.

[0005] In some instances, the present disclosure describes a medical device system including a catheter and a flaring device. The catheter includes an elongated body extending along a central longitudinal axis and defining a lumen terminating at an access port. The flaring device includes a housing and a pin. The housing includes an inner surface defining a cavity shaped to receive at least a portion of the catheter. The inner surface of the housing is configured to engage an outer surface of the catheter proximal to the access port. The pin is configured to advance into the access port of the catheter when at least a portion of the catheter is positioned in the cavity to flare the access port, thereby defining a flared lip extending away from the central longitudinal axis.

[0006] In some instances, the present disclosure describes a method comprising positioning at least one access port of a catheter in a cavity of a housing of a flaring device. The catheter comprises an elongated body extending along a central longitudinal axis and defining a lumen terminating at the access port. The flaring device comprises a housing and a pin. The housing comprises an inner surface defining a cavity shaped to receive at least a portion of a catheter comprising an access port. The inner surface of the housing is configured to engage an outer surface of the catheter proximal to the access port. The method further comprises, when at least one access port of the catheter is positioned in the cavity of the housing, advancing the pin into the access port of the catheter to flare the access port to increase the cross-sectional size of the access port.

[0007] The details of one or more aspects of the disclosure are set forth in the drawings and description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 is a conceptual side view of an exemplary medical device system including a catheter and an outer catheter, shown in cross-section.

[0009] Figure 2A is a conceptual longitudinal cross-sectional view of an exemplary medical device system depicting an access port of a catheter positioned within a lumen of an outer catheter and with a medical device inserted therein.

[0010] Figure 2B is along Figure 2A The line 2B-2B in Figure 2A A conceptual cross-sectional view of an exemplary medical device system is depicted.

[0011] Figure 3A is a conceptual longitudinal cross-sectional view of an exemplary medical device system depicting a flared access port of a modified catheter positioned within a lumen of an outer catheter and with a medical device inserted therein.

[0012] Figure 3B is along Figure 3A The line 3B-3B in Figure 3B A conceptual cross-sectional view of an exemplary medical device system is depicted.

[0013] Figure 4 is a conceptual side view of an exemplary medical device system including a flared pin and a catheter.

[0014] Figure 5 is a conceptual plan view of an exemplary medical device system including a catheter and a catheter expansion device including a housing and an expansion pin.

[0015] Fig. 6A and 6Bare photographs depicting top and side views of an exemplary catheter prior to flaring the access port, and Figure 6C and 6D are photographs showing front and side views of the catheter after flaring the access port.

[0016] Figure 7 is a flow chart depicting an exemplary technique for improving an access port of a catheter. DETAILED DESCRIPTION

[0017] In some instances, a flaring device including a pin is configured to improve the access port of the lumen of the catheter, such as by increasing the cross-sectional size of the access port. As discussed in further detail below, increasing the cross-sectional size of the access port, referred to herein as "flaring" of the access port, can widen the access port without increasing the outer cross-sectional diameter of other portions of the catheter (e.g., the distal portion), which can facilitate the introduction of a medical device into the lumen of the catheter without adversely affecting the guideability of the catheter through the patient's vascular system.

[0018] The pin of the flaring device is configured to be advanced into the access port of the catheter, and such as by making the catheter wall that limits the access port change size and / or shape to increase the cross-sectional dimensions of at least a portion of the access port.For example, the distance selected by the pin being advanced into the access port can make at least a portion of the access port flared in the radial direction.The flared portion of the entry point defines the flared lip of the catheter.The flared lip can include at least one of the selected lengths of the selected direction, selected cross-sectional dimensions (for example, diameter or width) relative to the access port, the unflared portion from the access port to the catheter, or can extend along the arc of the selected angle of the outer periphery of the subtended access port.In some instances, flaring the access port can facilitate the introduction of medical devices into the catheter lumen, and the guiding property of the catheter passing through the patient's vascular system can not be adversely affected.By flaring the access port, the access port entering the catheter lumen can better correspond to the internal diameter of the second catheter, for example, compared with the unflared catheter, the catheter is positioned in the second catheter.Although the second catheter is mainly referred to as an outer catheter or a guide catheter in this article, the second catheter can be the catheter of any suitable type.

[0019] In some instances, the catheter may include a guide extension catheter including a push assembly and an elongated body having distal and proximal access ports. A guide extension catheter ("GEC") may include a rapid exchange percutaneous intervention (PCI) device. The elongated body of the GEC defines at least one lumen through which a medical device (e.g., a catheter, a guidewire, a filter, a stent delivery system, etc.), a therapeutic agent, or other element may be introduced into the patient's vascular system or other tissue site. The elongated body may be coupled to a push assembly having a lower profile than the elongated body and facilitating the pushability of the GEC through an outer catheter and / or through the patient's vascular system. In some instances, the push assembly may include an elongated member and an anchoring member positioned at the distal end of the elongated member.

[0020] Due to the flexibility and lower profile of GEC, it may be more suitable for guiding through such severe tortuosity and / or calcification than outer catheter (e.g., guide catheter). In some instances, the clinician can push the GEC out of the distal end of the outer catheter when the outer catheter approaches such areas that the outer catheter is difficult or impossible to extend through. In some instances, when the GEC was pushed out of the distal end of the outer catheter, the GEC can be said to "stretch out" the outer catheter. In some instances, the GEC can provide additional backup support for the delivery of medical devices, therapeutic agents or other elements introduced into the vascular system or other tissue sites of the patient via the outer catheter.

[0021] In some cases, clinicians can select an outer catheter with a specific outer diameter (and corresponding inner diameter) and a GEC with an outer diameter less than the inner diameter of the outer catheter. Clinicians can select a GEC with a smaller diameter so that the GEC can be introduced into the inner lumen of the outer catheter. In addition, clinicians can select a GEC with a smaller outer diameter so that the GEC can be guided to a target site that is relatively difficult to reach. Compared with an outer catheter with a larger outer diameter or a GEC with a larger outer diameter, when guiding the vascular system of a patient, a GEC with a smaller outer diameter can provide, for example, improved conveying capacity and / or size advantages. As an example, clinicians can use a guiding catheter with an inner diameter of 7Fr and a GEC with an outer diameter of 5Fr. As another example, clinicians can use a guiding catheter with an outer diameter of 7Fr and a GEC of 7Fr, which can be designated as such because it is configured to be received in the inner lumen of a 7Fr guiding catheter, but in fact has an outer diameter less than 7Fr, for example, less than 7Fr by approximately 0.3mm. This difference in the outer diameter of the GEC and the inner diameter of the outer catheter may be referred to as GEC mismatch.

[0022] During the selected medical device is conveyed via GEC and outer catheter, GEC mismatch may cause a part of medical device to be stuck at the access port of GEC.For example, the tip or other leading edge parts of the medical device that is positioned in the outer catheter lumen of outer catheter and is guided into the GEC lumen may be stuck on the access port of GEC.Therefore, extra power may be needed to force medical device to enter the GEC lumen via the access port and / or the clinician may need to spend extra time to attempt to introduce medical device into the GEC lumen via the access port, such as by taking out medical device and realigning medical device with the GEC access port relative to the GEC access port.The tip or other leading edge parts of medical device may include the leading edge pillars of the far-end of catheter, stent, radiation fluorescence marking band, the leading edge of inflatable air bag, or other features of medical device.In order to reduce the interception of medical device on the access port of GEC, the flaring device described herein, system and technology can be used for improving the access port of GEC, so that the outer diameter of GEC is matched with the internal diameter of the guiding catheter better.Like this, described flaring device, system and technology can reduce the above described inconvenience associated with GEC mismatch.

[0023] Figure 1 is a conceptual side view of an exemplary medical device system 100 including a catheter 102 and an outer catheter 104. The catheter 102 includes an elongated body 106 having an access port 108, a push assembly 110, and a handle 112. In some examples, the catheter 102 can include a GEC.

[0024] The catheter 102 defines a longitudinal axis X extending in Figure 1 106 is shown as the central longitudinal axis of the elongated body 106. In some examples, the push assembly 110 may include an elongated member 109 and an anchoring member 111. The anchoring member 111 may be positioned at a distal portion of the elongated member 109 and fixed to a proximal portion of the elongated body 106 proximal to the access port 108. For example, the anchoring member 111 may extend between layers of material forming the elongated body 106, may be adhered to a portion of the elongated body 106, or both. The elongated body 106 defines a proximal end 114 and a distal end 116. In some examples, the maximum cross-sectional dimension of the elongated body 106 between the proximal end 114 and the distal end 116 may be less than the cross-sectional dimension of the access port 108. The elongated body 106 is configured to provide a delivery member on the catheter 102 that can extend distally of the outer catheter 104 to extend from the distal end of the outer catheter 104 and effectively extend the reach of the outer catheter 104 within the patient's vascular system. Extending the reach of outer catheter 104 may enable delivery of devices, agents, and / or any other suitable elements to target sites that may be difficult to reach with outer catheter 104 .

[0025] In some embodiments, the elongated body 106 includes a tapered portion 118, a proximal portion 120, and a distal portion 122. The tapered portion 118, the proximal portion 120, and the distal portion 122 may be integrally formed, or separate components that are adhered or otherwise connected together. The tapered portion 118 of the elongated body 106 tapers toward the central longitudinal axis X in the proximal direction. The tapering of the elongated body 106 at the tapered portion 118 may make it easier to retract the elongated body 106 into the outer catheter 104. For example, during or after use of the catheter 102, the clinician may wish to retract at least a portion of the elongated body 106 into the outer catheter 104 by retracting the push assembly 110 proximally relative to the outer catheter 104. The tapered portion 118 may allow the elongated body 106 to enter the outer catheter 104 more smoothly.

[0026] The proximal portion 120 and the distal portion 122 can have similar or different hardnesses. For example, the distal portion 122 can have a hardness greater than the hardness of the proximal portion 120. In other examples, the distal portion 122 can have a hardness less than the proximal portion 120. The harder proximal portion 120 can help maintain the integrity of the proximal portion of the lumen 105 of the elongated body 106, which can help introduce a medical device from the entry port 108 into the lumen 105 without adversely affecting the guideability of the catheter 102 through the patient's vascular system. For example, the harder proximal portion 120 can help the entry port 108 and the most proximal portion of the elongated body 106 resist deformation to help maintain lumen integrity. In some examples, the proximal portion 120 can be about 1 centimeter (cm) to about 4 cm long, such as about 2.5 cm long or about 1.25 cm long. In some examples, the distal portion 122 can be about 15 cm to about 27 cm long, such as about 24 cm to about 26 cm long, or about 25 cm long. The length can be measured along the longitudinal axis X.

[0027] The outer catheter 104 defines an outer catheter lumen 124, through which the catheter 102 can be introduced to enter a distal target site in, for example, the patient's vascular system. Therefore, at least a portion of the outer catheter 104 can be configured to surround the catheter 102. In some instances, the outer catheter 104 can include a guide catheter. The outer catheter 104 can also define a distal opening 126, and in some instances, at least a portion of the catheter 102 can be configured to extend through the distal opening 126 and the distal side of the outer catheter 104. For example, at least a portion of the elongated body 106 of the catheter 102 can be configured to extend out of the distal opening 126 of the outer catheter 104 to extend through severe tortuosity or calcification in a body vessel. The catheter 102 can have a smaller radial profile and can be more flexible than the outer catheter 104, so that it can more easily pass through severe tortuosity or calcification in a body vessel than the outer catheter 104.

[0028] In some examples, in order to enable the catheter 102 to be introduced into the outer catheter lumen 124 and slide within the outer catheter lumen 124, the maximum cross-sectional dimension (e.g., outer periphery or outer radial profile) of the elongated body 106 of the catheter 102 can be smaller or differently shaped than the maximum cross-sectional dimension of the inner periphery (e.g., inner radial profile) of the outer catheter 104. In other words, the outer periphery of the catheter 102 may not match the inner periphery of the catheter 104. For example, in the case where the catheters 102, 104 have a circular cross-section, the inner diameter of the catheter 104 (defining the lumen 124) can be greater than the outer diameter of the elongated body 106. The lip 128 of the entry port 108 of the elongated body 106 is configured to reduce the mismatch of the outer periphery of the catheter 102 with the inner periphery of the catheter 104. For example, as discussed below, the lip 128 can be a flared lip that flares radially outward relative to the central longitudinal axis X to reduce the space between the entry port 108 and the wall of the outer catheter 104 defining the lumen 124.

[0029] The access port 108 can extend from the proximal end 130 to the distal end 132 along the length of the elongated body 106 (the length is measured along the longitudinal axis X). In some examples, due to the tapered shape of the tapered portion 118 of the elongated body 106, the access port 108 can be angled from the distal end 132 to the proximal end 130. The access port 108 can include substantially straight or curved edges. In some examples, the access port 108 can be formed by shaving at least a portion 118 of the elongated body 106. In some examples, the access port 108 can have a length of about 2 centimeters (cm) to about 10 cm (e.g., 2 cm to 10 cm or close to 2 cm to 10 cm, to the extent allowed by manufacturing tolerances), such as about 3.5 cm to about 4.5 cm or about 4 cm, measured from the proximal end 130 to the distal end 132 along the longitudinal axis X. It is believed that a tapered access port 108 having a relatively long length and angled from distal end 132 to proximal end 130 may facilitate smooth delivery of a medical device, such as an interventional medical device, into lumen 105 of elongated body 106 via access port 108 by guiding the medical device into lumen 105 .

[0030] The lip 128 is configured to increase the cross-sectional size of the periphery of the access port 108. Generally, the lip 128 can include any suitable shape or size to more closely match the periphery of the elongated body 106 with the inner periphery of the conduit 104 at the lip 128. In some examples, the lip 128 is asymmetrical relative to the central longitudinal axis X. In some examples, the angle of the lip 128 relative to the central longitudinal axis X is greater than 0 degrees to about 45 degrees (e.g., as shown in FIG. Figure 3AThe angle θ shown is shown. In some examples, the length of the lip 128 in a direction parallel to the longitudinal axis X is about 3 millimeters (mm) to about 5 mm. In some examples, the periphery of the lip 128 can subtend an angle from about 45 degrees to about 315 degrees. The shape and / or size of the lip 128 can be selected to define a relatively smooth transition between the elongated body 106 and the outer catheter 104, for example, when only a portion of the elongated body 106 extends distally from the distal opening 126 of the outer catheter 104 while another portion remains within the lumen 124 of the outer catheter 104 and / or when the proximal end of the elongated body 106 abuts the distal end of the outer catheter 104. Additionally, or alternatively, when the elongated body 106 is at least partially within the outer catheter 104, the lip 128 can provide a relative sliding fit within the outer catheter 104.

[0031] In some examples, a relatively smooth transition and / or a sliding fit between the lip 128 and the inner surface of the outer catheter 104 can provide certain advantages. For example, a medical device and / or other element can be more easily advanced from the lumen 124 of the outer catheter 104 into the lumen 105 of the elongated body 106 because the transition between the lumen 124 and the lumen 105 can be relatively smooth so that the delivered component does not get stuck at the entry port 108 and / or the transition from the lumen 124 to the lumen 105. As another example, when the fluid is delivered through the outer catheter lumen 124 into the elongated body lumen 105, the lip 128 can reduce leakage of the fluid from the distal opening 126 of the outer catheter 104. In some examples, flaring the entry port 108 can facilitate the introduction of a medical device into the catheter lumen without adversely affecting the guideability of the catheter 102 through the patient's vasculature.

[0032] Although the entry port 108 of the slender body 106 is depicted as being positioned within the lumen 124 of the outer catheter 104 so that an interventional medical device or another medical device can be introduced from the lumen 124 of the outer catheter 104 into the lumen 105 of the slender body 106 without leaving the lumen 124, in other instances, the catheter 102 can extend beyond the distal opening 126 of the outer catheter 104 so that the proximal end 114 of the slender body 106 is distal to the distal opening 126.

[0033] Figure 2A is a conceptual longitudinal cross-sectional view of an exemplary medical device system 200 depicting the access port 208 of the catheter 202 positioned within the lumen 224 of the outer catheter 204 and with the medical device 234 inserted therein. Figure 2B yes Figure 2A A conceptual cross-sectional view of an exemplary medical device system 200 is depicted. The catheter 202 and the outer catheter 204 can be the same or substantially similar to the catheter 102 and the outer catheter 104, respectively, as described above with reference to Figure 1As discussed, except for the differences described herein. For example, the catheter 202 includes a push assembly 210 coupled to an elongated body 206. The elongated body 206 extends along a longitudinal axis and defines an entry port 208 that enters a lumen 205. The entry port 208 extends along the length of the elongated body 206 from a proximal end 230 to a distal end 232. In addition, the outer catheter 204 defines a lumen 224 through which the catheter 202 can pass.

[0034] like Figure 2A As shown, the access port 208 does not include a lip, and the catheter 202 and the outer catheter 204 define a mismatch 236. As discussed above, the mismatch 236 can include a difference between the outer diameter of the catheter 202 and the inner diameter of the outer catheter 204. Although discussed as a difference in diameter, in other examples, the difference can be another cross-sectional size or shape with respect to the catheter 202 and the outer catheter 204. In some examples, the mismatch 236 can be from about 0.33 mm to about 2 mm, such as about 0.5 mm to about 1 mm. Although the mismatch 236 is depicted as a gap extending within the lumen 224 between the upper surface of the elongated body 206 of the catheter 202 and the inner surface of the catheter 202, in some examples, the mismatch 236 can include a gap extending around any portion of the periphery of the elongated body 206.

[0035] In some instances, when medical device 234 is introduced from lumen 224 of outer catheter 204 toward catheter 202, mismatch 236 may cause at least a portion of medical device 234 to become stuck on access port 208. Medical device 234 may include any suitable medical device, such as, but not limited to, a catheter, a guidewire, a filter, a stent delivery system, a therapeutic agent delivery device, or other element introduced into a patient's vasculature or other tissue site. In some instances, medical device 234 may include lumen 238 ( Figure 2B ), so that the medical device 234 can be advanced over the guidewire 240. When the leading edge of the medical device 234 contacts the access port 208, the mismatch 236 may cause a portion of the medical device 234 to get stuck at the access port 208. For example, the leading struts of the stent of the medical device 234 may protrude in the radial direction, so that the medical device 234 may get stuck on the access port 208. In some instances, the clinician may not be able to apply enough pushing force to push the medical device 234 through the access port 208 when it is stuck at the access port 208, or the clinician must reposition one or more of the guidewire 240, the medical device 234, or the catheter 202 and try to advance the medical device through the access port 208 again. In order to reduce the medical device 234 getting stuck on the access port 208, a flaring device may be used to modify the access port 208, such as flaring the access port 208 to better match the outer diameter of the elongated body 206 with the inner diameter of the catheter 204.

[0036] Figure 3A is a conceptual longitudinal cross-sectional view of an exemplary medical device system 300 depicting a flared access port 308 of a modified catheter 302 positioned within a lumen 324 of an outer catheter 304 and with a medical device 334 inserted therein. Figure 3B is along Figure 3A The line 3B-3B in Figure 3A 2 and 3. A conceptual cross-sectional view of an exemplary medical device system 300 is shown in FIG. 3. The catheter 302 and the outer catheter 304 can be the same or substantially similar to the catheter 202 and the outer catheter 204, respectively, as described above with reference to FIG. Figure 2A and 2B As discussed, except for the differences described herein. For example, catheter 302 includes a push assembly 310 and an elongated body 306. Elongated body 306 extends along a longitudinal axis and defines a lumen 305 and an entry port 308 that enters lumen 305. Entry port 308 extends along the length of elongated body 306 from proximal end 330 to distal end 332. Outer catheter 304 defines a lumen 324 through which catheter 302 can pass. By advancing medical device 334 over a guidewire 340 extending through lumen 338 of medical device 334, medical device 334 can pass from lumen 324 of outer catheter 304 through lumen 305 of entry catheter 302.

[0037] like Figure 3A As shown, the access port 308 defines a lip 328. The lip 328 is configured to reduce mismatch between the catheter 302 and the outer catheter 304 (eg, as described above with reference to FIG. 3 ). Figure 2A and 2B Mismatch 236 discussed). In some examples, the angle θ of the lip 328 relative to the longitudinal axis X of the catheter 302 can be greater than 0 degrees to about 60 degrees, such as greater than about 0 degrees to about 45 degrees. The lip 328 can include (or define) at least one of an arc of a selected orientation relative to the entry port 308, a selected cross-sectional dimension (e.g., diameter or length), a selected length L of the unflared portion 342 of the elongated body 306 of the catheter 302 from the entry port 308, or a selected angle to the periphery of the entry port 308. By flaring the entry port 308, for example, the periphery of the catheter 302 can better correspond to the inner diameter of the second catheter 304 (referred to herein as the outer catheter) compared to an unflared catheter.

[0038] In some examples, the lip 328 can be asymmetric with respect to the longitudinal axis X. For example, the direction of the lip 328 can extend primarily in the y-direction (the orthogonal xy axis is at Figure 3Aand other figures, which is for ease of description only and does not give any particular intended direction of use). In other words, the lip 328 can extend in a radial direction away from a nominally planar elongated body 106 (e.g., a plane of the elongated body 106 extending parallel to the x-axis before flaring the entry port 308), with flaring being more predominant in the y-direction. In other examples, the lip 328 can be oriented in any suitable direction. For example, only one longitudinal half of the entry port 308 can extend radially away from the central longitudinal axis X to define the lip 328. In some examples, features of the catheter 302, such as, for example, the push assembly 310, can reduce or prevent flaring of the entry port 308 at a circumferential portion 311 of the elongated body 306 that is directly adjacent to the push assembly 310. For example, the stiffness of the push assembly 310 relative to the elongated body 306 can prevent the elongated body 306 from flaring in a radial direction.

[0039] In some examples, the outer cross-sectional dimension (e.g., diameter) of the flared access port 308 is substantially similar to the inner cross-sectional dimension (e.g., diameter) of the outer catheter 304. That is, the access port 308, including the lip 328, can define an outer surface of the catheter 302 that substantially matches (e.g., matches or nearly matches) the inner diameter of the outer catheter 304. In this way, the flared access port 308 can help reduce or even eliminate GEC mismatch and free space created between the elongated body 306 and the interior of the outer catheter 304, which can cause medical devices to become stuck at the leading edge of the access port 308. Additionally, or alternatively, the flared access port 308 can facilitate the introduction of medical devices into the lumen 305 of the catheter 302 without adversely affecting the guideability of the catheter 302 through the patient's vasculature.

[0040] In some examples, the length L of the lip 328 in a direction parallel to the longitudinal axis X can be about 3 millimeters (mm) to about 5 mm. In some examples, the length L of the lip 328 can be selected to provide a selected flexibility of the lip 328. For example, a lip having a relatively shorter length L can be less flexible than a lip having a relatively longer length L. In some examples, a more flexible lip 328 can have a size of the lip 328 equal to or greater than an inner dimension of the outer catheter 304. For example, when positioned within the lumen 324, the lip 328 can bend to match the size or shape of the inner surface of the outer catheter 304.

[0041] In some examples, the lip 328 extends along an arc 344 that subtends any suitable angle to the periphery of the access port 308. For example, Figure 3B As depicted, the arc subtends an angle of approximately 180 degrees. In other examples, the angle may be between about 45 degrees and about 360 degrees, such as about 45 degrees to about 315 degrees.

[0042] In some examples, the lip 328 can reduce the mismatch 336 to less than about 2 mm, such as less than about 0.5 mm, compared to a mismatch without the lip 326 (e.g., mismatch 236). By reducing the size of the mismatch 336, the medical device 334 can be guided from the lumen 324 of the outer catheter 304 into the lumen 305 of the catheter 302 with a lower likelihood of getting stuck on the access port 308 or otherwise interfering with the trajectory of the medical device 334 as it is advanced into the outer catheter lumen 305.

[0043] The following is discussed in detail Figure 4 and 5 An exemplary device configured to expand the access port of a catheter is depicted, referred to herein as a flaring device. In some embodiments, the described flaring device may include a plurality of flaring devices, each flaring device being configured to be used with a selected catheter size and / or to produce a selected flare. For example, a first flaring device may be used with a 7Fr catheter to expand the access port to substantially correspond to 8Fr, and a second flaring device may be used with a 5Fr catheter and be configured to expand the access port to substantially correspond to 7Fr. In this way, a clinician may select a flaring device corresponding to a selected catheter size and a selected flare size.

[0044] Figure 4 402. The pin 450 is configured to be advanced into the entry port 408 of the catheter 402 to form the lip 428. For example, advancing the flaring pin 450 into the entry port 408 can increase the cross-sectional size of the entry port 408. The catheter 402 can be similar to the one described above with reference to FIG. Figure 3A and 3B The catheter 302 discussed is the same or substantially similar. For example, the catheter 402 includes a push assembly 410 and an elongated body 406. The elongated body 406 extends along a longitudinal axis and defines a lumen 405 that terminates at an entry port 408. In some examples, the medical device system 400 can include an outer catheter (e.g., outer catheter 304) and / or a medical device (e.g., medical device 334).

[0045] The pin 450 can be formed of any suitable material having a suitable hardness to deform the access port 408 of the catheter 402 to define the lip 428. In some examples, the pin 450 can include a metal, such as, but not limited to, stainless steel, titanium, or any combination thereof. In some examples, the pin 450 can include a relatively rigid plastic (e.g., more rigid than the elongated body 406 of the catheter 402), such as, but not limited to, epoxy, high-density polyethylene, polyvinyl chloride, polycarbonate, acrylic resin, or any combination thereof. In some examples, the pin 450 can include metal and plastic.

[0046] In some examples, the pin 450 is configured to expand a selected periphery (e.g., only a portion of the periphery) of the access port 408 of the catheter 402. For example, the distal portion 452 of the pin 450 can define a conical shape. As an example, the distal end 454 of the pin 450 can have a cross-sectional dimension (e.g., diameter) that is smaller than the cross-sectional dimension of the unexpanded configuration of the access port 408. In this way, the distal end 454 can be inserted into the lumen 405 of the elongated body 406 via the access port 408, for example, by a clinician. The pin 450 can taper from a first cross-sectional dimension at the proximal portion 456 of the pin 450 to a second cross-sectional dimension that is smaller than the first cross-sectional dimension at the distal end 454. The taper can be substantially constant, vary in taper (e.g., increase or decrease taper), be stepped, or otherwise define a shape that is configured to deform at least a portion of the access port 408 to define a selected shape of the lip 428.

[0047] In some examples, the distal portion 452 of the pin 450 can define a conical shape having a central axis 453 that is eccentric relative to the central longitudinal axis X. As a result of the eccentricity, the pin 450 can cause the lip 428 to be asymmetric relative to the longitudinal axis X. For example, the lip 428 can extend radially away from the central longitudinal axis X more primarily in the y-direction, or only one longitudinal half of the access port 408 can flare radially outward. In this way, the pin 450 can be configured to flare the access port 408 in a selected direction, rather than radially outward in all directions about the central longitudinal axis X.

[0048] In some instances, the pin 450 can be configured to expand the access port 408 by cold expansion, e.g., without applying heat to the catheter 102. In some instances, the pin 450 can include a heating element (not shown). An exemplary heating element can include, for example, a resistive metal coil that extends through a portion of the interior of the pin 450 and is coupled to a power source. When an electric current is applied to the metal coil, the temperature of the metal coil may increase and thereby heat the pin 450 to a selected temperature. The temperature can be selected to soften and / or at least partially melt the material of the elongated body 406 of the catheter 402. In some instances, heat can be applied by a heating element that is not located within the pin 450, e.g., the heating element can be located in a housing configured to surround at least a portion of the catheter 402 (e.g., see reference 402). Figure 5 By softening and / or at least partially melting the material of the elongated body 406 of the catheter, the pin 450 can more easily deform the access port 408 to define the lip 428. In some examples, once cooled, the elongated body 406 can better retain the selected shape of the lip 428 than the pin 450 without the heating element. In this way, the heating element can facilitate the formation of the lip 428.

[0049] In some examples, the flare pin 450 can be configured to be manipulated directly by a clinician. For example, the clinician can push the flare pin 450 into the access port 408. In some examples, the flare pin 450 can be coupled to the housing so that the housing can engage at least a portion of the catheter 102, and the clinician can manipulate the flare pin 450 or a member coupled to the flare pin 450 to advance the flare pin 450 into the access port 408.

[0050] Figure 5 is a conceptual plan view of an exemplary medical device system 500 including a catheter 502 and a catheter expansion device 560 having a housing including a first housing portion 562A and a second housing portion 562B (collectively referred to as "housing portions 562") and an expansion pin 550 ("pin 550"). Although reference is made to Figure 5 The discussion includes two housing parts, but in other examples, the catheter expansion device 560 can include a single integral housing. The catheter 502 and the pin 550 can be respectively as described above with reference to Figure 4 The catheter 402 and pin 450 discussed are identical or substantially similar, except for the differences described herein. For example, the catheter 502 includes a push assembly 510 and an elongated body 506 terminating at an entry port 508. The pin 550 includes a distal portion 552 configured to expand a selected periphery of the entry port 508 of the catheter 502.

[0051] In some examples, housing portion 562 is configured to engage outer surface 503 of catheter 502 proximal to access port 508. For example, housing portion 562 may include respective inner surfaces 564A and 564B (collectively, "inner surface 564") defining respective cavities 566A and 566B (collectively, "cavities 566"). Cavity 566 may be configured to receive at least a portion of catheter 502 including access port 508. For example, housing portion 562 may be coupled via hinges 568A and 568B such that housing portion 562 may be coupled to a catheter 502 such as a catheter 502 having a plurality of cavities 566A and 566B. Figure 5 The depicted housing portions 562 move between an open configuration receiving the conduit 502 and a closed position where the two housing portions 562 engage the conduit 502. As such, the first housing portion 562A and the second housing portion 562B are configured to move relative to each other to enclose at least a portion of the conduit 502.

[0052] In some examples, the shape of the inner surface 564 of the housing portion 562 can be configured to orient the access port 508 of the catheter 502 in a selected orientation relative to the pin 550. For example, the inner surface 564 can include one or more protrusions or depressions that correspond to features of the catheter 502, such as the access port 508 or the push assembly 510, so that the catheter 502 is received in the cavity 566 in a predetermined orientation. In this way, the housing portion 562 can be configured to receive the catheter 502 in a predetermined orientation relative to the pin 550 and help prevent the clinician from inadvertently inserting the catheter 502 into the housing portion 562 in an unintended orientation.

[0053] In some instances, the cavity 566 can be shaped to correspond to a selected flaring shape of the access port 508. For example, after the access port 508 has been flared, the cavity 566 can define a selected shape of the periphery of the elongated body 506. In this way, the housing portion 562 can be used to control the flaring of the access port 508, for example, to prevent the pin 550 from being pushed too far into the lumen 505, which can define a lip having too long a length (measured along the longitudinal axis of the catheter 502). As another, the housing portion 562 defining a pre-formed cavity 566 corresponding to the desired amount of flaring of the access port 508 can help ensure that the access port 508 is fully flared by providing tactile feedback to the clinician. The tactile feedback can be in the form of, for example, that the clinician cannot push the pin 550 further into the housing portion 562.

[0054] In some examples, the pin 550 can be mechanically coupled to the housing portion 562 and can be configured to travel in a predetermined direction, such as a linear direction. For example, the pin 550 can travel in one or more grooves along one or more tracks or similar structures that extend parallel to the x-axis and are defined by the inner surface 564B of the first housing portion 562A. In this way, the second housing portion 562B can be mechanically coupled to the pin 550 in a sliding engagement. By being mechanically coupled to the second housing portion 562B in a sliding engagement, the pin 550 can be moved between a first position and a second position, in which the housing portion 562 is configured to receive the conduit 502 in the cavity 566B, such as indicated by arrow 570, and in which the pin 550 is positioned relative to the conduit 502 received in the housing portion 562 to flare the entry port 508 of the conduit 502, such as indicated by arrow 572.

[0055] In some examples, after positioning the catheter 502 within the cavity 566B and before advancing the pin 550 into the access port 508, the clinician can move the housing portion 562 into a closed configuration to surround and engage at least a portion of the catheter 502 including the access port 508. For example, moving the housing portion 562 into the closed configuration can engage the catheter 502 via a friction fit between at least a portion of the inner surface 564 and at least a portion of the elongated body 506 to help maintain the catheter 502 in position relative to the housing portion 562. In this way, the inner surface 564 of the housing portion 562 is configured to engage the outer surface of the catheter 502 proximate the access port 508 so that the pin 550 can be advanced into the lumen 505 via the access port 508 to increase the cross-sectional size of the access port 508.

[0056] In some examples, the catheter dilation device 560, e.g., the pin 550, may include a button 558 or other spherical structure to facilitate advancing the pin 550 into the lumen 505 of the catheter 502. For example, a clinician may apply a pushing force to the button 558 to advance the pin 550 in the direction indicated by the arrow 572. The button 558 may enable the clinician to apply a greater or more consistent pushing force to the pin 550 to advance the pin 550 into the lumen 505 via the access port 508 in the absence of the button 558 and the spring 568. For example, the button 558 may provide a structure for the clinician to grasp and may also serve as a stop to prevent the pin 550 from advancing into the lumen 505 of the catheter 502 beyond a desired point, which may result in the lip having a longer length than desired.

[0057] In some examples, the catheter expansion device 560 may include a recessed return device 568. The recessed return device 568 may be configured to return the pin 550 to its original position when the force pushing the pin 550 into the access port 508 of the catheter 502 is released. For example, the recessed return device 568 may apply a force to the pin 550 in the direction indicated by the arrow 570. Figure 5 As depicted, the recess return device 568 comprises a coil spring. In other examples, the recess return device 568 may comprise one or more different mechanical springs or pneumatic cylinders.

[0058] Fig. 6A and 6B are photographs depicting top and side views of an exemplary catheter 602 prior to flaring the access port 608, and Figure 6C and 6D 602 is a photograph showing a front view and a side view of the catheter 602 after the inlet port 608 is expanded. The catheter 602 can be similar to the above reference Figures 1 to 5The catheters 102, 202, 302, 402, and 502 discussed are the same or substantially similar except for the differences described herein. For example, the catheter 602 includes a push assembly 610 having an anchor member 611 coupled to an elongated body 606. The elongated body 606 can extend along a longitudinal axis and define a lumen 605 that terminates at an access port 608. The access port 608 extends along the length of the elongated body 606 from a proximal end (not shown) to a distal end 632.

[0059] like Fig. 6A and 6B As shown, the access port 608 does not include a lip prior to flaring the access port 608. In the example where the catheter 602 is a guide extension catheter, the catheter 202 can define a mismatch with the guide catheter (not shown). Figure 2A and 2B As discussed, in some cases, the mismatch can be about 0.33 mm to about 2 mm, such as about 0.5 mm to about 1 mm. To reduce the possibility of a medical device getting stuck on the access port 608, a flaring device, such as catheter flaring device 560, can be used to modify the access port 608, such as flaring the access port 608 to better match the outer diameter of the elongated body 606 to the inner diameter of a second catheter, such as a guide catheter.

[0060] like Figure 6C and 6D As shown, after the entry port 608 has been expanded, for example using the catheter expansion device 560, the entry port 608 defines a lip 628. Figure 3A and 3B As discussed, the lip 628 is configured to reduce the mismatch between the catheter 602 and, for example, the inner diameter of the guide catheter. The lip 628 can include at least one of a selected orientation relative to the entry port 608, a selected cross-sectional dimension (e.g., diameter or length), a selected length L of the unflared portion of the elongated body 606 of the catheter 602 from the entry port 608, or an arc of a selected angle to the outer periphery of the entry port 608. By flaring the entry port 608, for example, the outer periphery of the catheter 602 can better correspond to the inner diameter of the second catheter compared to an unflared catheter.

[0061] The medical device systems described herein can be used to flare an access port of a catheter, such as a guide extension catheter. Figure 7 is a flow chart illustrating an exemplary technique for improving the access port of a catheter. Figure 5 The described medical device system 500 describes Figure 7 The technology is illustrated, but the technology can be used with other medical device systems, such as one or more of medical device systems 100 , 200 , 300 , or 400 .

[0062] Figure 7 The illustrated technique includes positioning at least the entry port 508 of the catheter 502 in a cavity 566 of a housing portion 562 of a flaring device 560. As discussed above, the catheter 502 can include an elongated body 506 extending along a longitudinal axis and defining a lumen 505 terminating at the entry port 508. Also, as discussed above, the flaring device 560 can include a housing portion 562 and a pin 550. The housing portion 562 can include an inner surface 564 defining a cavity 566 shaped to receive a portion of the catheter 602. The inner surface 564 of the housing portion 562 can be configured to engage an outer surface 503 of the catheter 502 proximate the entry port 508.

[0063] Figure 7 The illustrated technique also includes advancing the pin 550 into the lumen 505 via the access port 508 of the catheter 502 to flare the access port 508. The flared access port 508 can define a flared lip (e.g., flared lip 428) extending away from the central longitudinal axis X of the elongated body 506. In an example where the shape of the inner surface 564 of the housing portion 562 corresponds to the selected flared shape of the access port 508 of the catheter 502, advancing the pin 550 can include advancing the pin 550 until the flared lip contacts the inner surface 564 of the housing portion 562. In this way, the inner surface 564 can include a positive stop that prevents the access port 508 from over-flaring.

[0064] In instances where the flaring device 560 further includes a recessed return device 568, the technique may include releasing the force applied to advance the pin 550 into the lumen 505 via the access port 508 of the catheter 502 after advancing the pin 550. In some instances, the recessed return device 568 may automatically return the pin 550 to the original position after releasing the force. The original position may include a position of the pin 550 such that the pin 550 does not extend into the lumen 505 via the access port 508. By automatically returning the pin 550 to the original position, the clinician may not need to manually return the pin 550 to the original position.

[0065] In an example where the expansion device 560 includes a heating element configured to at least soften the material of the conduit 502, the technique can include applying heat to at least a portion of the conduit via the heating element. Heating at least a portion of the conduit 502 can reduce the amount of force required to expand the access port 508.

[0066] Clinicians can use the reference at any appropriate time, such as before or during a medical procedure in a clinic (e.g., a catheterization lab). Figure 7 The access port 508 of the catheter 502 may be modified using the techniques described herein or other devices and techniques described herein.

[0067] The following items present examples of subject matter described herein.

[0068] Item 1. A device comprising: a shell comprising an inner surface defining a cavity, the cavity being configured to receive at least a portion of a catheter having an access port, wherein the inner surface of the shell is configured to engage an outer surface of the catheter proximate the access port; and a pin configured to be pushed into the access port of the catheter to increase the cross-sectional size of the access port when at least the portion of the catheter is positioned in the cavity.

[0069] Clause 2. The device of Clause 1, wherein the pin is configured to flare at least a portion of the access port of the catheter.

[0070] Clause 3. The device of clause 1 or 2, wherein the distal portion of the pin defines a conical shape.

[0071] Clause 4. The device of any one of Clauses 1 to 3, wherein the distal portion of the pin defines a conical shape that is eccentric relative to a central longitudinal axis of the proximal portion of the pin.

[0072] Clause 5. The device of any one of clauses 1 to 4, wherein the pin is mechanically coupled to the housing in a sliding engagement.

[0073] Clause 6. The device according to any one of clauses 1 to 5, further comprising a recessed return device, which is configured to return the pin to an original position when the force that pushes the pin into the access port of the catheter is released.

[0074] Clause 7. The device according to clause 6, wherein the recess return device comprises a spring or a pneumatic cylinder.

[0075] Clause 8. The device of any one of Clauses 1 to 7, further comprising a heating element configured to soften the material of the conduit.

[0076] Clause 9. The device of any one of Clauses 1 to 8, wherein the shape of the inner surface of the housing corresponds to a selected flared shape of the entry port of the conduit.

[0077] Clause 10. The device of any one of Clauses 1 to 9, wherein the shape of the inner surface of the housing is configured to orient the access port of the catheter in a selected orientation relative to the pin.

[0078] Clause 11. A device according to any one of clauses 1 to 10, wherein the housing comprises a first portion and a second portion mechanically connected to the first portion by one or more hinges, wherein the first portion and the second portion are configured to move relative to each other to enclose at least the portion of the conduit.

[0079] Item 12. A medical device system comprising: a catheter comprising an elongated body extending along a central longitudinal axis and defining a lumen terminating in an access port; and a flaring device comprising: a shell comprising an inner surface defining a cavity, the cavity being shaped to receive at least a portion of the catheter, wherein the inner surface of the shell is configured to engage an outer surface of the catheter proximate the access port; and a pin configured to be advanced into the access port of the catheter when at least the portion of the catheter is positioned in the cavity to flare the access port, thereby defining a flared lip extending away from the central longitudinal axis.

[0080] Clause 13. The medical device system of Clause 12, wherein the flared lip of the access port tapers in a distal direction toward the central longitudinal axis.

[0081] Clause 14. The medical device system of Clause 12 or 13, wherein the flared lip is asymmetric relative to the central longitudinal axis.

[0082] Clause 15. The medical device system of any one of Clauses 12 to 14, wherein the flared lip is at an angle of greater than 0 degrees to about 45 degrees relative to the central longitudinal axis.

[0083] Clause 16. The medical device system of any one of Clauses 12 to 15, wherein the flared lip has a length in a direction parallel to the central longitudinal axis of about 3 mm to about 5 mm.

[0084] Clause 17. The medical device system of any one of Clauses 12 to 16, wherein an outer periphery of the flared lip subtends an angle from about 45 degrees to about 315 degrees.

[0085] Clause 18. A medical device system according to any one of clauses 12 to 17, wherein the catheter is a guide extension catheter comprising the slender body and a pushing assembly, the pushing assembly comprising a slender member and an anchoring member, wherein the maximum cross-sectional dimension of the slender member is smaller than the cross-sectional dimension of the access port, wherein the anchoring member is positioned at the distal end of the slender member and fixed to the slender body proximate the access port.

[0086] Clause 19. The medical device system of any one of clauses 12 to 18, wherein the pin defines a conical shape having a central axis that is eccentric relative to the central longitudinal axis of the catheter when at least the portion of the catheter is positioned in the cavity.

[0087] Clause 20. The medical device system of any one of Clauses 12 to 19, wherein the pin is mechanically coupled to the housing in a sliding engagement.

[0088] Clause 21. A medical device system according to any one of Clauses 12 to 20, wherein the expansion device further comprises a recessed return device, which is configured to automatically return the pin to its original position when the force that pushes the pin into the access port of the catheter is released.

[0089] Clause 22. The medical device system of claim 21, wherein the recess return device comprises a spring or a pneumatic cylinder.

[0090] Clause 23. The medical device system of any one of Clauses 12 to 22, wherein the expansion device further comprises a heating element configured to at least soften a material of the catheter.

[0091] Clause 24. The medical device system of any of Clauses 12 to 23, wherein the shape of the inner surface of the housing corresponds to a selected flared shape of the access port of the catheter.

[0092] Clause 25. The flaring device of any one of Clauses 12 to 24, wherein the shape of the inner surface of the housing is configured to orient the entry port of the conduit in a selected orientation relative to the pin.

[0093] Item 26. A method comprising: positioning at least one access port of a catheter in a cavity of a shell of a flaring device, wherein the catheter comprises an elongated body extending along a central longitudinal axis and defining a lumen terminating in the access port, and wherein the flaring device comprises: the shell comprising an inner surface defining the cavity, the cavity being shaped to receive at least a portion of the catheter comprising the access port, wherein the inner surface of the shell is configured to engage an outer surface of the catheter proximate the access port; and a pin; and when the at least one access port of the catheter is positioned in the cavity of the shell, pushing the pin into the access port of the catheter to flare the access port, thereby increasing the cross-sectional size of the access port.

[0094] Clause 27. The method of Clause 26, wherein advancing the pin into the access port of the catheter increases a cross-sectional size of the access port at least by flaring a lip of the catheter.

[0095] Clause 28. The method of clause 26 or 27, wherein advancing the pin comprises advancing the pin until the access port contacts the inner surface of the housing.

[0096] Clause 29. A method according to any one of clauses 26 to 28, wherein the expansion device further includes a recessed return device, wherein the method further includes, after advancing the pin, releasing the force applied to advance the pin into the entry port of the catheter, wherein the recessed return device automatically returns the pin to its original position after releasing the force.

[0097] Clause 30. The method of any one of Clauses 26 to 29, wherein the expansion device further comprises a heating element configured to at least soften the material of the conduit, wherein the method further comprises applying heat to at least the portion of the conduit via the heating element.

[0098] Clause 31. The method of any one of Clauses 26 to 30, further comprising selecting the flaring device based on a desired flared shape of the access port of the catheter.

[0099] Various examples have been described. These and other examples are within the scope of the following claims.

Claims

1. A medical device system, comprising: a catheter comprising an elongated body extending along a central longitudinal axis and defining a lumen terminating in an access port; as well as The expansion device comprises: a housing including an inner surface defining a cavity configured to receive at least a portion of a catheter having an access port, wherein the inner surface of the housing is configured to engage an outer surface of the catheter proximate the access port; a pin configured to be advanced into the access port of the catheter when at least the portion of the catheter is positioned in the cavity to increase a cross-sectional size of the access port to define a flared lip extending away from the central longitudinal axis; and a recessed return device, the recessed return device being a spring and configured to return the pin to an original position upon release of the force that urged the pin into the access port of the catheter; The catheter is a guide extension catheter comprising the slender body and a pushing assembly, the pushing assembly includes a slender member and an anchoring member, wherein the maximum cross-sectional dimension of the slender member is smaller than the cross-sectional dimension of the access port, wherein the anchoring member is positioned at the distal end of the slender member and fixed to the slender body near the access port. 2 . The medical device system of claim 1 , wherein the flared lip of the access port tapers in a distal direction toward the central longitudinal axis.

3. The medical device system of claim 1, wherein the flared lip is asymmetric relative to the central longitudinal axis.

4. The medical device system of claim 1, wherein the flared lip is at an angle greater than 0 to 45 degrees relative to the central longitudinal axis. 5 . The medical device system of claim 1 , wherein the flared lip has a length in a direction parallel to the central longitudinal axis of 3 mm to 5 mm.

6. The medical device system of claim 1, wherein an outer periphery of the flared lip subtends an angle from 45 degrees to 315 degrees.

7. The medical device system of claim 1, wherein the pin defines a conical shape having a central axis that is eccentric relative to the central longitudinal axis of the catheter when at least the portion of the catheter is positioned in the cavity.

8. The medical device system of claim 1, wherein the pin is mechanically coupled to the housing in a sliding engagement.

9. The medical device system of claim 1, wherein the recess return device comprises a spring or a pneumatic cylinder.

10. The medical device system of claim 1, wherein the expansion device further comprises a heating element configured to at least soften a material of the catheter.

11. The medical device system of claim 1 , wherein the inner surface of the housing has a shape corresponding to a selected flared shape of the access port of the catheter.

12. The medical device system of claim 1, wherein the shape of the inner surface of the housing is configured to orient the access port of the catheter in a selected orientation relative to the pin.

13. A method of assembling a medical device system, comprising: Positioning at least one access port of a catheter in the cavity of a housing of a flaring device, wherein the catheter comprises an elongated body extending along a central longitudinal axis and defining a lumen terminating in the access port, and wherein the flaring device comprises: a housing including an inner surface defining a cavity configured to receive at least a portion of a catheter having an access port, wherein the inner surface of the housing is configured to engage an outer surface of the catheter proximate the access port; a pin configured to be advanced into the access port of the catheter when at least the portion of the catheter is positioned in the cavity to increase a cross-sectional size of the access port to define a flared lip extending away from the central longitudinal axis; and a recessed return device, the recessed return device being a spring and configured to return the pin to an original position upon release of the force that urged the pin into the access port of the catheter; and When the at least one access port of the conduit is positioned in the cavity of the housing, advancing the pin into the access port of the conduit to flare the access port, thereby increasing a cross-sectional size of the access port; The catheter is a guide extension catheter comprising the slender body and a pushing assembly, the pushing assembly includes a slender member and an anchoring member, wherein the maximum cross-sectional dimension of the slender member is smaller than the cross-sectional dimension of the access port, wherein the anchoring member is positioned at the distal end of the slender member and fixed to the slender body near the access port.

14. The method of claim 13, wherein advancing the pin into the access port of the catheter increases the cross-sectional size of the access port at least by flaring a lip of the catheter.

15. The method of claim 13, wherein advancing the pin comprises advancing the pin until the access port contacts the inner surface of the housing.

Citation Information

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